New TB Trial Data Shows Sorfequiline Could Dramatically Shorten Treatment Time

New TB Trial Data Shows Sorfequiline Could Dramatically Shorten Treatment Time

By, Admin 21 November 2025

A major breakthrough in tuberculosis (TB) drug development is emerging. New phase 2 clinical trial results presented by TB Alliance at the Union World Conference on Lung Health indicate that sorfequiline (TBA-876) — a next-generation diarylquinoline antibiotic — could significantly improve and shorten TB treatment when used in the investigational SPaL regimen (sorfequiline + pretomanid + linezolid).

The findings come from the global NC-009 trial, a multi-country study that tested whether sorfequiline could outperform current treatments and address drug-resistant TB challenges.

Sorfequiline Outperforms Bedaquiline — and Shows Potential to Reduce Treatment Time

One of the strongest signals from the trial: sorfequiline demonstrated greater activity than bedaquiline, the current gold-standard diarylquinoline used in TB treatment.

Key highlights from NC-009:

  • The 100 mg SPaL regimen showed stronger anti-TB activity than standard therapy (HRZE)
  • SPaL’s safety profile was comparable to HRZE in people with drug-sensitive TB
  • Results suggest a pathway to shorter treatment durations, a critical need in TB care

The trial was conducted across 22 sites in South Africa, the Philippines, Georgia, Tanzania, and Uganda, reflecting real-world, high-burden environments.

A Major Step Toward Ultra-Short Treatment for Both DS-TB and DR-TB

TB Alliance believes these results may accelerate the shift toward ultra-short TB regimens, applicable to both drug-sensitive and drug-resistant TB.

“We now have an opportunity to shorten treatment even further,”
— Dr. Mel Spigelman, President & CEO, TB Alliance

The organization previously developed BPaL, a six-month regimen for drug-resistant TB, which dramatically simplified treatment and improved global outcomes. Sorfequiline could be the next leap forward.

Why Sorfequiline Matters

Both sorfequiline and bedaquiline belong to the diarylquinoline class, blocking the TB bacteria’s energy-production enzyme. But sorfequiline has important advantages:

Potential benefits over bedaquiline

  • Stronger anti-mycobacterial activity (up to 10-fold higher in vitro)
  • Lower risk of QT prolongation
  • Potential efficacy against bedaquiline-resistant strains
  • Fewer adverse events in phase 1 studies

If successful, sorfequiline could become a safer and more reliable anchor drug for TB therapy.

Experts See Hope for Faster, Simpler TB Treatment

Clinicians involved in the study emphasized the significance of these results.

“Advancements like sorfequiline make once-aspirational goals, like TB eradication, increasingly possible.”

— Dr. Rod Dawson, Principal Investigator, NC-009

Participants also reported positive experiences:

“The treatment was shorter and easier than I expected.”

— Thuto Pulane, NC-009 participant

SPaL: Toward an All-Oral, Ultra-Short TB Regimen

TB Alliance plans to:

  • Launch a Phase 3 SPaL trial in 2026
  • Strengthen partnerships with India, China, Indonesia, South Africa, and Brazil
  • Explore a long-acting injectable version (LAI) that could potentially reduce treatment to as little as one month

Both sorfequiline and SPaL are being developed as all-oral therapies, eliminating the burden of injections and reducing healthcare system strain.

Why New Treatments Are Urgently Needed

TB remains one of the world’s deadliest infectious diseases. Current treatment often requires:

  • 4–6 months of daily pills for DS-TB
  • Up to 2 years of treatment for drug-resistant TB
  • High pill burden (20+ pills/day in older regimens)
  • Toxic side effects and high drop-off rates

These barriers fuel TB’s global spread and mortality. Novel regimens like SPaL seek to solve exactly these problems.

A Look Back: Impact of TB Alliance’s Earlier Breakthrough

TB Alliance introduced pretomanid as part of the BPaL regimen, which:

  • Became the first TB drug developed by a non-profit to gain regulatory approval
  • Cut treatment duration for drug-resistant TB to six months
  • Has resulted in over 210,000 ordered treatment courses
  • Helped save an estimated 11,000 lives and $100 million USD globally

Sorfequiline could build on — and surpass — this progress.

About TB Alliance

TB Alliance is a global non-profit organization committed to developing faster, safer, and more accessible TB treatments. The organization is supported by a broad coalition of governments, global health funds, and philanthropic organizations.

Their goal is simple: bring TB treatment into the modern era and ultimately eliminate the disease worldwide.

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